Recently, the Food and Drug Administration (FDA) warned the public (again) about the purchase and use of the counterfeit version of the dengue vaccine Qdenga. In an advisory, it said the Qdenga vaccine is not yet registered with the agency and that its application for registration is still on process. The application for registration of Qdenga was submitted to FDA way back on April 26, 2023. Qdenga is the second dengue vaccine to be prequalified by the World Health Organization after Dengvaxia.

Qdenga is now in use in over 40 countries around the world, including the EU, where it had been used in trials involving millions of persons without significant risks, complications and no safety signals. Likewise, it has been proven very effective in preventing dengue fever (an 80 percent reduction in infections in those vaccinated with two doses) with marked reduction in dengue mortality and hospitalizations. Serologically, individuals given two doses showed an increase in antibody against all four dengue serotypes.

Qdenga is generally well tolerated, with no significant safety concerns identified up to seven years following primary vaccination in the clinical studies or post-marketing data to date (which has been provided to the FDA but it refused to receive the data). Even other countries where dengue is not prevalent had given approval for registration of Qdenga vaccine.

Now, why is Qdenga still not given approval locally, when the application had been submitted more than three years ago? Granted, the FDA had questions about it, but Takeda Pharmaceuticals Ltd., the manufacturer of Qdenga, had replied and given their response to the questions the FDA had posed.

It cannot be denied that the hesitancy the FDA is displaying about Qdenga is due to the Dengvaxia controversy. It even cited the prevalence of dengue serotype 3 locally which may cause more severe dengue if given the Qdenga vaccine. Sorry, but the serotype prevalence changes from year to year, which makes this FDA reason invalid. Additionally, Qdenga has been found to be effective against all serotypes.

The Qdenga vaccine trials experience did not show any severe dengue among its participants. In fact, what the FDA is concerned about is the antibody-dependent enhancement (ADE) that was the later finding of Sanofi Pasteur if the Dengvaxia vaccine recipient was “dengue-naïve,” (the individual had not been previously infected by dengue). Let it be clear that this statement was made on a theoretical basis, meaning, it had not been observed in the Dengvaxia clinical trials involving millions of individuals. Unfortunately, the Public Attorney’s Office chose to ride on this issue and pursued a crusade against Dengvaxia.

So, we are now at this point when we still don’t have a dengue vaccine. The DOH is trying to downplay the dengue issue by citing lower number of cases in the past few months. The statement is facetious in that the number of dengue cases is usually lower in the dry months but will definitely pick up when the rainy season is underway.

Our health authorities’ mantra to prevent dengue is still the 5S campaign which has not dented the statistics of dengue infections and deaths, which are preventable in the light of a safe and effective vaccine, except that we can’t avail of it due to the FDA’s stalling on its approval.

So, can we blame people who are availing of fake vaccines if no legal product is available? In fact, many parents are bringing their children to other countries just to have the Qdenga vaccine for their children.

Plus, the economic costs of the dengue outbreaks locally run into hundreds of millions, not to mention the preventable deaths.

When should the FDA man up and shrug off the fear that the PAO may go after its officials if they approve Qdenga like what happened with Dengvaxia?

Speaking of which, the Dengvaxia court trials on the first set of cases ended with the judge tossing out the charges due to lack of evidence, because the so-called “experts” of the prosecution were deemed not to be experts at all.

Even that fear of the “ill effects” of Dengvaxia is unfounded, since the judge did not even bother to call on the defense to present its own evidence since there was no basis for the charges.

The Department of Justice has likewise withdrawn its charges on the additional Dengvaxia cases citing lack of evidence.

It's time to clear the poisonous atmosphere generated by the hysteria over the Dengvaxia vaccine when nothing has been proven so far.

The FDA should look at the science, not the hysteria, since it’s their mandate to approve good medicine based on scientific data. Otherwise, their officials should just resign and let other more principled and courageous people take over.

Can we have the real dengue vaccine please, FDA?